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United States · US · US:71335-1016_f623a735-841a-4e73-ae38-e4d5d27a055f
Tizanidine
Orange BookUNIISPLATC M03BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 10
- ndc117133510160112 TABLET in 1 BOTTLE (71335-1016-0)
- ndc11713351016130 TABLET in 1 BOTTLE (71335-1016-1)
- ndc11713351016260 TABLET in 1 BOTTLE (71335-1016-2)
- ndc11713351016390 TABLET in 1 BOTTLE (71335-1016-3)
- ndc117133510164120 TABLET in 1 BOTTLE (71335-1016-4)
- ndc11713351016520 TABLET in 1 BOTTLE (71335-1016-5)
- ndc11713351016645 TABLET in 1 BOTTLE (71335-1016-6)
- ndc117133510167140 TABLET in 1 BOTTLE (71335-1016-7)
- ndc11713351016884 TABLET in 1 BOTTLE (71335-1016-8)
- ndc11713351016928 TABLET in 1 BOTTLE (71335-1016-9)
Annotations
UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
A076416
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "B53E3NMY5C",
"rxcui": "236460",
"inchikey": "ZWUKMNZJRDGCTQ-UHFFFAOYSA-N",
"display_name": "TIZANIDINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"22ea819a-2aaa-44e0-a350-258541b11220": {
"match": "brand_token",
"title": "TIZANIDINE HYDROCHLORIDE CAPSULE [KANCHAN HEALTHCARE INC]",
"spl_version": "9",
"published_date": "2026-05-21"
}
},
"productid": "71335-1016_f623a735-841a-4e73-ae38-e4d5d27a055f",
"productndc": "71335-1016",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076416",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Sep 29, 2003"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "Sep 29, 2003"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIZANIDINE HYDROCHLORIDE",
"proprietary_name": "Tizanidine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076416",
"marketing_category": "ANDA",
"nonproprietary_name": "Tizanidine",
"start_marketing_date": "20031211",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code M03BX02.
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